Assessment | Who to complete/action | Timeline (weeks post-randomisation) | |||
Screening | Baseline | Week 6 | Week 12 | ||
Baseline data (collected from case notes) | |||||
Demographic data, eligibility, written informed consent | Research nurse | X | |||
Background and medical history | Research nurse | X | |||
Referral to local participating community palliative care team | Research nurse | X | |||
Schedule initial appointment within 1 week; deliver usual care OR usual care and introduction of trial interventions as determined by randomisation allocation | Palliative care team | X | |||
Clinical follow-up data (collected from case notes or hospice system for example, SystmOne) | |||||
Use of Intervention and usual care details | Palliative care team | X | |||
All-cause mortality | Palliative care team | X | |||
Serious adverse event reporting | Palliative care team | Ongoing reporting | |||
Clinical follow-up data (collected from case notes, hospital system for example, SystmOne and PPM database) | |||||
Healthcare use | Research nurse | X | |||
Pain medication | Research nurse | X | X | ||
Date of referral to community palliative care, no and details of contacts | Research nurse | X | |||
All-cause mortality | Research nurse | X | |||
Serious adverse event reporting | Research nurse | Ongoing reporting | |||
Patient-completed questionnaires (completed in clinic at baseline and at home/over telephone for follow-up visits) | |||||
BPI assessment | Trial researcher | X | X | X | |
7-point global rating change of pain | Trial researcher | X | X | ||
Healthcare use (Health Economics questionnaire) | Trial researcher | X | X | X | |
Patient Pain Questionnaire40 | Trial researcher | X | X | X | |
EQ-5D41 | Trial researcher | X | X | X | |
EORTC QLQ-C3042 | Trial researcher | X | X | X | |
Clinical follow-up data (collected via GP practice) | |||||
Date of referral to community palliative care | Trial researcher | Ongoing reporting | |||
Survival status | Trial researcher/Leeds Institute of Clinical Trials Research | Ongoing reporting | |||
Routine monitoring data | |||||
Uptake (patients and palliative care nurse) and patient-reported pain diaries | Trial researcher* | Ongoing reporting | |||
Qualitative participant interviews | Trial researcher* | ~6 or 12 weeks post-randomisation | |||
Participant qualitative palliative care nurse end of trial interviews | Trial researcher* | End of trial |
*Conducted through a different trial researcher involved in patient-completed questionnaire follow-up and clinical follow-up.
BPI, Brief Pain Inventory; EORTC, European Organization for Research and Treatment of Cancer; GP, general practitioner.